An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam

NCT01886300 | Terminated Results

• 1 other identifier: ML27807
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current local labeling in routine clinical practice in Vietnam. Eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment

  A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to \<2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.

  6 months

• Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment

  HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.

  12 months

Secondary Outcomes (6)

• Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period

  Up to 24 months

• Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period

  Up to 24 months

• Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period

  Up to 24 months

• Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period

  Up to 24 months

• Incidence of Normalization of Serum Alanine Transaminase

  Up to 24 months

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with HBeAg-positive chronic hepatitis B treated with Pegasys

You may qualify if:

• Adult patients, \>/= 18 years of age
• HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis
• Elevated serum ALT \> ULN (upper limit of normal) but \</= 10 x ULN
• Patients with no contra-indications to Pegasys therapy as detailed in the label
• Written informed consent where local regulations allow or require it

You may not qualify if:

• Patients should not receive concomitant therapy with telbivudine
• Co-infection with hepatitis A, hepatitis B or HIV
• Pregnant or breastfeeding women
• Patients with depression/mental diseases
• Neutrophil at baseline \> 90.000/mm3
• Abnormal T4 or TSH

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Hanoi, Vietnam

Location

Unknown Facility

Ho Chi Minh City, District 5, Vietnam

Location

Unknown Facility

Hochiminh City, Vietnam

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 25, 2013
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 22, 2016
• Results First Posted: June 22, 2016

Record last verified: 2016-05

Locations

VN (3)